GSK
MSAT Drug Product Lead (LAI - Long-Acting Injectable)
MSAT Drug Product Lead (LAI - Long-Acting Injectable)
Updated 3 days ago
WarePermanentOn-SiteFull-TimeLead
Updated 3 days ago
Description
Position Summary
You will manage the Manufacturing Science and Technology (MSAT) Drug Product technical delivery for a Long-Acting Injectable (LAI) product family, with a primary focus on New Product Introduction (NPI) and successful product launches, including delivering successful right-first-time product qualifications, within sterile/aseptic drug product manufacturing environments. You will work closely with R&D, manufacturing sites, quality, regulatory and external partners to ensure safe, robust and compliant supply. We value practical problem solvers who communicate clearly, collaborate across functions, and build knowledge that others can use. This role offers visible impact, strong development opportunities and a chance to help GSK unite science, technology and talent to get ahead of disease together.
Responsibilities
Expectations
Location: Ideally you will be based at one of the following manufacturing sites: Ware (Hertfordshire, UK), Barnard Castle (Durham, UK) or Parma (Emilia-Romagna, Italy), but we can also consider high-caliber applicants based at other GSK Global Supply Chain (GSC) manufacturing sites in Europe.
Basic Qualifications
Preferred Qualifications
GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, parental status, national origin, age, disability, genetic information, military service or any basis prohibited under federal, state or local law.
You will manage the Manufacturing Science and Technology (MSAT) Drug Product technical delivery for a Long-Acting Injectable (LAI) product family, with a primary focus on New Product Introduction (NPI) and successful product launches, including delivering successful right-first-time product qualifications, within sterile/aseptic drug product manufacturing environments. You will work closely with R&D, manufacturing sites, quality, regulatory and external partners to ensure safe, robust and compliant supply. We value practical problem solvers who communicate clearly, collaborate across functions, and build knowledge that others can use. This role offers visible impact, strong development opportunities and a chance to help GSK unite science, technology and talent to get ahead of disease together.
Responsibilities
- Act as the single technical point of contact for the drug product portfolio, owning technical risk, decision-making and product knowledge.
- Lead and deliver technology transfers to internal sites and external manufacturers, including transfer packages, training and readiness reviews.
- Manage continued process verification, process performance qualification and change management to maintain product robustness and compliance.
- Drive right-first-time execution of product qualification activities (e.g., PPQ/qualification readiness), managing appropriate governance through the relevant stage-gate forums as the program approaches PPQ, ensuring robust data, clear acceptance criteria and effective issue resolution.
- Define and maintain product control strategy and technical risk assessments. Translate that knowledge into clear documentation for operations.
- Support regulatory submissions and post approval inspections by providing technical input, comparability strategies and supporting documentation.
- Manage cross-functional investigations, root cause analysis and corrective actions for complex deviations and quality events.
Expectations
- Work in a matrix environment and build strong relationships across functions and sites.
- Make technical recommendations that balance speed, quality and patient safety.
- Share knowledge through clear documentation, training and mentoring of operational teams.
- Ensure data and documentation meet regulatory and GSK quality standards.
- Demonstrate strong understanding of sterile/aseptic drug product manufacturing, including contamination control expectations, and apply this to technical decision-making, investigations and change management.
- Drive continuous improvement and apply practical lessons to prevent recurrence.
- Travel to manufacturing sites and partner organisations as required.
Location: Ideally you will be based at one of the following manufacturing sites: Ware (Hertfordshire, UK), Barnard Castle (Durham, UK) or Parma (Emilia-Romagna, Italy), but we can also consider high-caliber applicants based at other GSK Global Supply Chain (GSC) manufacturing sites in Europe.
Basic Qualifications
- Degree in a relevant technical, scientific or engineering discipline (for example pharmacy, chemistry, chemical/biochemical engineering).
- Experience with long-acting injectables, or other relevant aseptic formulations.
- Knowledge / experience in drug product manufacturing, MSAT, process development or technical transfer roles in the pharmaceutical industry.
- Practical knowledge of risk tools (for example FMEA), control strategy development and statistical concepts for CPV.
- Demonstrable experience of technology transfer, process validation or continued process verification.
- Knowledge of good manufacturing practice (GMP) and product lifecycle management principles.
- Experience working in cross-functional teams and managing stakeholder expectations.
Preferred Qualifications
- Experience preparing technical content for regulatory submissions and supporting inspections.
- Experience managing complex investigations and applying Lean / Six Sigma problem-solving (e.g., trained DMAIC facilitator).
- Experience working with contract manufacturing organisations (CMOs) or external partners.
- Demonstrable track record in coaching or managing small technical teams and cross-functional projects.
GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, parental status, national origin, age, disability, genetic information, military service or any basis prohibited under federal, state or local law.

